Objectives: Colistin is the first revived antibiotic to undergo substantial 'redevelopment' in academic settings. This study investigated the variation and accuracy of information in the summary of product characteristics (SPC) of intravenous colistin products approved in the European Union.
Methods: The dosing, indication and pharmacokinetic information in the SPCs of approved intravenous colistin products in 21 European countries were compared.
Results: In general, some SPCs have been updated over recent years though vital aspects of dosing recommendations, indications and pharmacokinetic information show a rather broad variation. The importance of a loading dose and of a daily dose >6 million international units in critically ill patients with good renal function is not considered in all SPCs. The pharmacokinetic section and dosing recommendations for special patient populations require careful review and updating, in order to take account of newly published data.
Conclusions: This study highlights the challenges of integrating new rapidly evolving scientific knowledge into approved SPCs in Europe.
Keywords: SPCs; antibacterial drugs; dosing; regulatory.
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